COVID-19: CDC, FDA and CMS Guidance
This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.
The Food and Drug Administration authorized for emergency use an armband device that screens people without COVID-19 symptoms for certain potential SARS-CoV-2 biomarkers, such as excessive blood clotting.
The Department of Health and Human Services (HHS) March 19 updated its guidance to hospitals on the reporting of COVID-19-related data.
The Food and Drug Administration yesterday updated the health care provider fact sheets for all three monoclonal antibody therapies authorized for emergency use to include information on whether SARS-CoV-2 variants may show resistance to that therapy.
For the first time, the Food and Drug Administration authorized marketing a SARS-CoV-2 diagnostic test beyond the public health emergency based on additional data. FDA previously authorized the BioFire Respiratory Panel 2.1 test for emergency use to detect SARS-CoV-2 and other respiratory pathogens…
The Centers for Disease Control and Prevention has created a federal classification scheme for SARS-CoV-2 variants and posted information on their prevalence in the United States.
The Food and Drug Administration launched a dashboard that will provide weekly updates on adverse events submitted to its adverse event reporting system for COVID-19 drugs and biological products authorized for emergency use.
The Centers for Disease Control and Prevention allocated $10 billion to states and territories from the American Rescue Plan Act to support testing to screen teachers, staff and students for COVID-19 to help reopen schools.
The Food and Drug Administration alerted clinical laboratories staff and health care providers to the potential for positive results from a test made by Roche Molecular Systems to simultaneously detect and differentiate SARS-CoV-2 and influenza A/B.
The Centers for Medicare & Medicaid Services, in collaboration with the Centers for Disease Control and Prevention, issued updated visitation guidance for nursing homes, noting that more than 3 million COVID-19 vaccine doses have been administered to nursing home residents and staff.
The Food and Drug Administration issued an emergency use authorization for a next generation sequencing test to aid in identifying individuals with an adaptive T cell immune response indicating recent or prior infection with SARS-CoV-2.